Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: TEVA GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
Austedo 12 mg prolonged-release tablets.
Austedo 24 mg prolonged-release tablets.
Austedo 30 mg prolonged-release tablets.
Austedo 36 mg prolonged-release tablets.
Austedo 42 mg prolonged-release tablets.
Austedo 48 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. Austedo 12 mg prolonged-release tablets: The tablets are round, blue, film-coated, with a diameter of approximately 9 mm and "Q12" printed in black ink on one side. Austedo 24 mg prolonged-release tablets: The tablets are round, purple, film-coated, with a diameter of approximately 9 mm and "Q24" printed in black ink on one side. Austedo 30 mg prolonged-release tablets: The tablets are round, light orange, film-coated, with a diameter of approximately 10 mm and "Q30" printed in black ink on one side. Austedo 36 mg prolonged-release tablets: The tablets are round, light purple, film-coated, with a diameter of approximately 10 mm and "Q36" printed in black ink on one side. Austedo 42 mg prolonged-release tablets: The tablets are round, orange, film-coated, with a diameter of approximately 10 mm and "Q42" printed in black ink on one side. Austedo 48 mg prolonged-release tablets: The tablets are round, pink, film-coated, with a diameter of approximately 10 mm and "Q48" printed in black ink on one side. |
Each prolonged-release tablet contains 12 mg of deutetrabenazine.
Excipient with known effect: Each prolonged-release tablet contains 0.32 mg of allura red AC.
Each prolonged-release tablet contains 24 mg of deutetrabenazine.
Excipient with known effect: Each prolonged-release tablet contains 0.94 mg of allura red AC.
Each prolonged-release tablet contains 30 mg of deutetrabenazine.
Excipients with known effect: Each prolonged-release tablet contains 0.45 mg of allura red AC and 0.14 mg of sunset yellow FCF.
Each prolonged-release tablet contains 36 mg of deutetrabenazine.
Excipients with known effect: Each prolonged-release tablet contains 0.70 mg of allura red AC and 0.03 mg of sunset yellow FCF.
Each prolonged-release tablet contains 42 mg of deutetrabenazine.
Excipients with known effect: Each prolonged-release tablet contains 1.21 mg of allura red AC and 1.17 mg of sunset yellow FCF.
Each prolonged-release tablet contains 48 mg of deutetrabenazine.
Excipient with known effect: Each prolonged-release tablet contains 0.83 mg of allura red AC.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Deutetrabenazine and the major circulating metabolites are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores in dopaminergic regions (e.g. striatum and cortex) of the brain. While the precise mechanism of action by which deutetrabenazine exerts its effects in the treatment of tardive dyskinesia is unknown, it is believed to be related to its effect as a depletor of monoamines from nerve terminals. |
| List of Excipients |
|---|
|
Tablet core: Butylhydroxyanisole (E320) Film-coating: Poly(vinyl alcohol) Austedo 12 mg Indigo carmine (E132) Austedo 24 mg Indigo carmine (E132) Austedo 30 mg Sunset yellow FCF (E110) Austedo 36 mg Indigo carmine (E132) Austedo 42 mg Sunset yellow FCF (E110) Austedo 48 mg Allura red AC (E129) Printing ink: Shellac |
PVC/PCTFE/PVC-Aluminium blisters.
Austedo 12 mg, 24 mg, 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (treatment initiation pack):
Pack of 42 prolonged-release tablets containing two wallet cards one with 21 (7 × 12 mg, 7 × 24 mg, 7 × 30 mg) and another one with 21 (7 × 36 mg, 7 × 42 mg, 7 × 48 mg) prolonged-release tablets.
Austedo 24 mg, 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (maintenance packs):
Packs of 28 and 84 prolonged-release tablets.
Not all pack sizes may be marketed.
TEVA GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
Austedo 12 mg, 24 mg, 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (treatment initiation pack):
EU/1/25/1956/001
Austedo 24 mg, 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (maintenance packs):
EU/1/25/1956/002 - 24 mg (28 prolonged-release tablets)
EU/1/25/1956/003 - 24 mg (84 prolonged-release tablets)
EU/1/25/1956/004 - 30 mg (28 prolonged-release tablets)
EU/1/25/1956/005 - 30 mg (84 prolonged-release tablets)
EU/1/25/1956/006 - 36 mg (28 prolonged-release tablets)
EU/1/25/1956/007 - 36 mg (84 prolonged-release tablets)
EU/1/25/1956/008 - 42 mg (28 prolonged-release tablets)
EU/1/25/1956/009 - 42 mg (84 prolonged-release tablets)
EU/1/25/1956/010 - 48 mg (28 prolonged-release tablets)
EU/1/25/1956/011 - 48 mg (84 prolonged-release tablets)
| Drug | Countries | |
|---|---|---|
| AUSTEDO | Estonia, Israel, Lithuania, United States |
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